Comparison of the Pharmacokinetics of Three Generic Medications and Their Respective Brand Preparations

NCT01400165 | Unknown Phase 1

• 1 other identifier: REB-2010023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Generic describes a pharmaceutical product that does not have a brand name or trademark. Generic medications should be the equivalent of brand medications. Only their price should be different. The active ingredient of the generic medication has to be within a window of 80 to 125% of the original in the blood. There are reports that this standard is not always followed after the medication has been on the market. Indeed, it was observed that some patients previously stable on original medications relapsed when switched to a generic. Several factors could account for this problem. Such problems have been reported for Pindolol, Quetiapine, and Trazodone. Some properties of specific brands of the generics and the original brands will be examined for these three medications. The three original medications used in this study are the Visken, the Seroquel, and the Desyrel. The three generics are the Teva-pindolol, the Teva-Quetiapine, and the Teva-Trazodone. They are all available on the Canadian market by prescription.

Conditions

Healthy

Keywords

Therapeutic Equivalency; Human Experimentation; Bioequivalence; Brand name; Generic; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Plasma levels of Medication

  0 to 48 hours after drug ingestion

Study Arms (3)

Desyrel/Teva-Trazodone

ACTIVE COMPARATOR

Both drugs will be given at the dose of 150 mg. A washout period (corresponding to 10 half-life of the active compound) will be respected after receiving each medication.

Drug: Trazodone; Procedure: Blood Collection

Visken/Teva-Pindolol

ACTIVE COMPARATOR

Both drugs will be given at the dose of 10 mg. A washout period (corresponding to 10 half-life of the active compound) will be respected after receiving each medication

Drug: Pindolol; Procedure: Blood Collection

Seroquel/Teva-Quetiapine

ACTIVE COMPARATOR

Both drugs will be given at the dose of 100 mg. A washout period (corresponding to 10 half-life of the active compound) will be respected after receiving each medication

Drug: Quetiapine; Procedure: Blood Collection

Interventions

Trazodone DRUG

each subject will be taken 1 tablet of Trazodone 150mg of each group (brand/generic)

Also known as: Desyrel, Teva-Trazodone

Desyrel/Teva-Trazodone

Quetiapine DRUG

each subject will be taken 1 tablet of Quetiapine 100mg of each group (brand/generic)

Also known as: Seroquel, Teva-Quetiapine

Seroquel/Teva-Quetiapine

Pindolol DRUG

each subject will be taken 1 tablet of Pindolol 10mg of each group (brand/generic)

Also known as: Visken, Teva-Pindolol

Visken/Teva-Pindolol

Blood Collection PROCEDURE

Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.

Desyrel/Teva-Trazodone; Seroquel/Teva-Quetiapine; Visken/Teva-Pindolol

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers (absence of diseases: psychiatric, physical, neurological, metabolic,...)

You may not qualify if:

• Psychiatric disorder
• Hepatic disease
• Renal disease
• Gastrointestinal disease
• Hematological disease
• Smokers
• Physical and/or neurological disease
• Positive urine drug screen
• Abnormal blood pressure
• Abnormal Electrocardiogram
• Abnormal urine/blood analysis (sodium, potassium, chloride, creatinine, urea, ALT, AST, total protein, glucose, and TSH)
• Taking medication
• Have donated 50 mL to 499 mL whole blood within 30 days and more than 499 mL whole blood within 56 days preceding entry into this study

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

University of Ottawa, Institute of Mental Health Research

Ottawa, Ontario, K1Z-7K4, Canada

RECRUITING

MeSH Terms

Interventions

Trazodone; Quetiapine Fumarate; Pindolol; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pierre Blier, MD, PhD

  University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit

  PRINCIPAL INVESTIGATOR

• Franck Chenu, PharmD, Phd

  University of Ottawa, Institute of Mental Health Research - Mood Disorders Research Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre BLIER, MD, PhD

CONTACT

613-722-6521; pierre.blier@rohcg.on.ca

Wendy Fusee, RN

CONTACT

613-722-6521; wendy.fusee@rohcg.on.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 22, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 22, 2011

Record last verified: 2011-07

Locations

CA (1)